The new medical device regulation system basically forms the medical supplies industry to be transformed and upgraded

Recently, the State Food and Drug Administration (CFDA) Medical Device Registration Division of the relevant person in charge of the 21st century economic report reporters said that at present, China's new medical device regulatory system has been basically formed, with more than 40 supporting normative documents, as well as more than 200 technical review guidelines.
it is also understood that China's medical device approval work has also entered the fast track. In October 2016, the CFDA issued a limited approval process for medical devices, giving priority to the diagnosis or treatment of rare diseases, malignant tumors, geriatric diseases and medical devices dedicated to children's clinical needs, as well as medical devices included in major national scientific and technological projects and key research and development programs.
At the recent 10th China (International) Medical Supplies Conference and China Medical Industry International Cooperation Forum, Zhou Hui, President of the China Medical and Health Products Import and Export Chamber of Commerce, said that the current medical device industry has entered a new normal of growth rate shift, structural optimization, new materials, new technologies, new processes, new ideas are constantly presented.
with the continuous development of social, economic and social culture, people pay more attention to health needs, and countries pay more attention to the development of medical and health services, so the medical device industry will continue to maintain a stable growth trend in the future. Zhou Hui pointed out.
Among them, in the past five years, China's medical supplies trade has made rapid progress, product types and quality continue to improve, product structure from low value-added to medium and high value-added transformation, manufacturing mode from label production transformation to the direction of original design manufacturers, import and export volume is also gradually expanding, from 7.586 billion U.S. dollars in 2012 to 8.62 billion U.S. dollars in 2016.
However, Meng Dongping, vice president of china Medical and Health Products Import and Export Chamber of Commerce, pointed out to the 21st Century Economic Report that in the international market, China's medical supplies have occupied more than 60% of the market share, but due to weak international market demand and increased competition led to market adjustment, China's medical supplies in 2016 showed a trend of increasing price increases and falls, the price war between enterprises is intensifying.
At present, the medical supplies industry production costs continue to rise, low-cost competition is not uncommon, product homogenization is serious, resulting in a decline in overall prices, profit margins, so that enterprises in the domestic and foreign markets have encountered greater challenges. On the whole, the market competition of medical supplies in China is fierce in the future, and the structural upgrading of medical supplies industry is the inevitable trend of development. (21st Century Economic Report)